Acute Circulatory Support System with Full MagLev Flow Technology

Clinical Evidence

Read journal articles, abstracts and other clinical evidence related to the CentriMag™ Acute Circulatory Support System with Full MagLev™ Flow Technology:

General Publications

  • Aziz et al., 2010
    A single-center retrospective analysis of 10 consecutive patients who received CentriMag ECMO support for cardiogenic shock refractory to conventional therapy. The average duration of ECMO was 5.8 days with 60% survival to discharge. There were no major device-related complications. CentriMag ECMO was easy to insert, functioned without error, and significantly reduced expected mortality.

  • Bhama et al., 2006
    A single-center retrospective analysis of 29 patients who received CentriMag System for right ventricular (RV) support for cardiogenic shock post-cardiotomy (24%), post-cardiac transplant (35%), and post-LVAD placement (41%). The mean support time was 8 days with 52% survival to discharge. Complications included infection (45%), arrhythmia (45%), reoperation for bleeding (35%), stroke (10%), and air embolism (3%). There were no device failures. The CentriMag System provides effective temporary support for RV failure with ease of implantation and a high rate of successful device weaning.

  • Zhang et al., 2006
    A computation and experimental study to analyze the hemodynamic and hemocompatibility performance of the CentriMag System using computational fluid dynamics (CFD)-based modeling. The results indicated no significant high shear stress in the pump. The 1.5mm gap passages between the outer rotor walls and the lower housing cavity provide very good surface washing and reduced shear stresses resulting in a low hemolysis rate of NIH=0.0029 without a decrease in the pump’s performance (pressure head: 352 mmHg at a flow rate of 5.0 L/min and a rotational speed of 4000 rpm).

CentriMag VAD PMA

  • Loforte et al., 2014
    A double-center retrospective analysis of the use of mechanical circulatory support devices in 116 acute or chronic end-stage heart failure patients. CentriMag was used as a temporary VAD in right-, left-, or biventricular configuration in 50 patients (43%) labeled as Group A. CentriMag was the only device used as an isolated RVAD in 24 patients (21%). Group B consisted of 66 patients (57%) implanted with long-term support devices including HeartMate I and II, Novacor, HVAD, Jarvik, InCor, and SynCardia. Kaplan-Meier method was used to calculate survival curves and determine survival outcomes for VAD patients and transplanted patients receiving no prior VAD support. Success was defined as recovery, heart transplantation, and hospital discharge.

    Group A had an overall success rate of 54% with a mean support time of 10.2 ± 6.6 days. 15 patients died on support. Adverse events included reoperation due to bleeding (36%), major cerebral events (10%), and pulmonary hemorrhage (2%). No device failures were noted.

    Group B had an overall success rate of 73% for LVAD and 47% for BiVAD. 73% of LVAD patients were discharged home and 18% died after discharging due to driveline infection (8%), cerebral hemorrhage (8%), and unknown cause in 1 patient.

    Overall, the rate of heart transplant was 26%. The overall 1- and 5-year survival rates after transplant were 73% and 60% respectively. When a decision to treat with VAD or TAH is made early, either modality can be used as an alternative to heart transplant, affording comparable early to mid-term outcomes.

  • McCormick et al., 2010
    A retrospective review from the Utah Artificial Heart Program database of 83 patients implanted with CentriMag temporary VAD in a right- (n=30), left- (n=8), biventricular (n=25), or cardiopulmonary support (CPS) (n=30) configuration. Outcomes included survival to discharge along with 30-day, 6-month, and 1-year survival rates for each configuration. The longest mean support duration was 11 days for RVAD configuration, while the shortest was 4 days for cardiopulmonary support. Survival to discharge was 60% for RVAD, 63% for LVAD, 40% for BiVAD, and 30% for CPS.

  • Thomas et al., 2011
    A retrospective review from the comprehensive UK Cardiothoracic Transplant Audit of 572 patients receiving a heart transplant in the UK between 2003 and 2008. 34 patients required CentriMag support for graft failure with 22 BiVADs, 10 RVADs, and 2 LVADs. There were no significant differences in transplant characteristics between cohorts.

    35% of patients were explanted with 9 patients surviving past 1-year with 3 dying post-explant on day 5, 20, and 71. 30-day survival was 50% (95% CI, 32-65) and 1-year survival was 32% (95% CI, 18-48). Patients who received a VAD for bridging prior to transplant had significantly better survival after CentriMag for graft failure (p=0.029). CentriMag support led to the salvage of 32% of patients with severe allograft failure.

  • John et al., 2011
    Two nonrandomized, multicenter pilot studies to evaluate the use of the CentriMag System. The first trial used CentriMag as an LVAD or BiVAD to treat patients in cardiogenic shock. The second utilized CentriMag as an RVAD after implantation of a commercially available LVAD. Success was defined as survival to 30 days after weaning, to transplant, or to long-term VAD.

    38 patients were supported at 7 centers (12 after cardiotomy, 14 after myocardial infarction, and 12 with RV failure after LVAD implant). Left- (n=8), right- (n=12), and biventricular (n=18) configurations were utilized. Mean support was 13 days with 47% surviving to to 30 days after weaning. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no device failures.

  • Takayama et al., 2014
    A single center retrospective analysis of 158 device runs in 143 patients receiving mechanical circulatory support as a bridge-to-decision in the setting of refractory cardiogenic shock. 71% of the patients were INTERMACS Registry profile 1 with several different device configurations (67% BiVAD, 26% RVAD, 8% LVAD). The median duration of support was 14 days with a 30-day survival of 69% and 1-year survival of 49%. 30% had myocardial recovery, 15% received implantable VAD, and 18% received heart transplantation. Complications included major bleeding (33%) and cerebrovascular accidents (14%). There were no pump failures or thrombosis.

  • Urban et al., 2015
    A single center retrospective analysis of 64 patients transplanted from a HeartMate II device. The patients were divided into two groups. Group 1 received an isolated LVAD (n=56) and Group 2 required RV mechanical support after LVAD placement (n=8). Early graft loss was 10.7% with an isolated LVAD and 25% with additional RVAD support (p=0.26). There were no differences in the rates of primary graft dysfunction, renal failure, and stroke between the two groups. The 3-year graft survival rate was 86 ± 5% in isolated LVAD and 75 ± 15% in LVAD + RVAD (p=0.326).

    Heart transplant recipients who require unplanned RV support after LVAD placement achieved comparable rates of early graft loss, renal failure, and stroke in comparison with an isolated LVAD. The small sample size suggests the need for further studies.

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